JMIR Publications

ABSTRACT

Background:

Perioperative bleeding and hemostatic disturbances are major causes of morbidity and mortality in pediatric cardiovascular surgery, particularly in procedures requiring cardiopulmonary bypass, with the risk potentially shifting toward either hemorrhage or thrombosis. Prothrombin complex concentrates (PCCs) have emerged as a targeted hemostatic strategy because they allow rapid replacement of vitamin K–dependent coagulation factors and have been used as an alternative to plasma for factor replacement, although their use requires monitoring for thrombotic risk. While the evidence on PCCs has increased considerably in adult cardiovascular surgery, evidence in the pediatric population remains limited, heterogeneous, and derived primarily from observational studies.

Objective:

This scoping review aims to map and characterize the available evidence on the perioperative use of PCCs in pediatric cardiovascular surgery.

Methods:

This scoping review follows the JBI methodology and was prospectively registered in OSF Registries. Nine information sources were searched: PubMed/MEDLINE, CENTRAL, EMBASE, LILACS, Epistemonikos, MedRxiv, Google Scholar, ClinicalTrials.gov, and the World Health Organization repository. Studies published from January 1, 1990, involving patients younger than 18 years undergoing cardiac or great-vessel surgery for congenital or acquired heart disease, with or without cardiopulmonary bypass, in whom PCCs were used perioperatively for the management of bleeding or coagulopathy will be included. Title and abstract screening was performed independently by two reviewers blinded to each other's decisions in Rayyan. Full-text eligibility is assessed by a primary reviewer, with independent verification of all exclusions by a second reviewer, and data extraction is performed using a standardized form. Results will be synthesized descriptively and narratively, without meta-analysis or formal risk-of-bias assessment, and reported in accordance with the PRISMA-ScR extension.

Results:

Searches were conducted between July 22 and 29, 2026, and retrieved 226 records (PubMed/MEDLINE: 67; CENTRAL: 7; EMBASE: 99; LILACS: 1; Epistemonikos: 14; MedRxiv: 0; Google Scholar: 10; ClinicalTrials.gov: 23; World Health Organization: 5). Title and abstract screening has been completed, and full-text eligibility assessment and data extraction are ongoing. The review is expected to be completed in December 2026.

Conclusions:

This scoping review will provide a structured map of the available evidence on the use of PCCs in pediatric cardiovascular surgery, describing populations, clinical indications, formulations, dosing regimens, monitoring strategies, reported outcomes, and thrombotic complications, and will identify evidence gaps that may inform future comparative studies and institutional hemostatic protocols. Clinical Trial: OSF Registries 10.17605/OSF.IO/AS7CB; https://doi.org/10.17605/OSF.IO/AS7CB